AI Earnings Predictions for Cytokinetics Incorporated (CYTK)

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EX-99.1

2 cytk-ex99_1.htm

EX-99.1

EX-99.1

Cytokinetics Reports First Quarter 2026 Financial Results and Provides Business Update

U.S. Launch of MYQORZO® (aficamten) in Late January Met with Strong Demand;

Over 275 HCPs Prescribed MYQORZO to an estimated 680 Patients in Q1

ACACIA-HCM Met Dual Primary Endpoints of KCCQ and Maximal Exercise Performance;

Full Results to be Presented at Upcoming Medical Congress

MYQORZO Approved by the European Commission for Adults with Symptomatic Obstructive HCM; Supplemental NDA for MAPLE-HCM Accepted for Filing by FDA with PDUFA Date of November 14, 2026

Net Product Revenues for MYQORZO of $4.8 Million for Initial Partial Quarter;

~$1.1 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026

SOUTH SAN FRANCISCO, Calif., May 5, 2026 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the first quarter of 2026.

“The U.S. launch of MYQORZO commenced strongly in late January and continues to accelerate. We promptly activated a solid prescriber base of early adopters and are encouraged by initial commercial metrics that are exceeding our expectations,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In addition, today we shared positive topline results from ACACIA-HCM in non-obstructive HCM showing that aficamten improved both symptoms and maximal exercise performance, a milestone achievement that opens the aperture for aficamten to potentially address the entire spectrum of HCM. We look forward to building on our strong start and driving meaningful progress for both the commercial launch of MYQORZO and the continued advancement of our pipeline.”

Q1 and Recent Highlights

Cardiac Muscle Programs

MYQORZO® (aficamten) (cardiac myosin inhibitor)

• Began U.S. commercial launch of MYQORZO for adults with symptomatic obstructive HCM (oHCM) in January, with drug availability beginning on January 27, 2026. Activated online portal for MYQORZO REMS simultaneous with drug availability, launched promotional patient and healthcare professional (HCP) marketing campaigns to educate and build on already strong HCP awareness, and began peer-to-peer education to accelerate adoption across the HCM community.

• Drove early launch momentum for MYQORZO with strong engagement, adoption and demand. As of March 31, 2026:

o Over 1,400 HCPs REMS certified

o Over 275 unique healthcare providers prescribed MYQORZO

o Approximately 680 patients prescribed MYQORZO

o Over 70% of patients on therapy on paid prescription

• Received approval from the European Commission (EC) for MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients.

• Advanced European commercial readiness activities ahead of first expected launch in Germany in Q2 2026. Completed hiring of our full team in Germany inclusive of sales, marketing, market access and medical.

• Announced positive topline results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 in both Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and maximal exercise performance (peak VO2). Statistically significant improvements compared to placebo were also observed in key secondary endpoints.

• The Supplemental New Drug Application for MAPLE-HCM was accepted for filing by the U.S. Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026.

• Submitted a Marketing Authorization Application for aficamten to Swissmedic. Aficamten has been granted Orphan Drug Status by Swissmedic.

• Aficamten was granted Orphan Drug Designation by the Japan Ministry of Health, Labour and Welfare for the treatment of patients with nHCM and pediatric patients with oHCM.

• Advanced the ongoing clinical trials program for aficamten:

o Continued conduct of the Japan cohort of ACACIA-HCM.

o Continued conduct of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.

o Continued patient enrollment in CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM. We expect to complete enrollment of the adolescent cohort in Q4 2026.

• Presented new analyses at the American College of Cardiology (ACC) Annual Scientific Session & Expo from SEQUOIA-HCM, MAPLE-HCM and FOREST-HCM supporting previously published data related to the safety and efficacy of aficamten in oHCM.

omecamtiv mecarbil (cardiac myosin activator)

• Continued conduct of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue patient enrollment th

8-K

0001061983false00010619832026-02-242026-02-24

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 24, 2026

Cytokinetics, Incorporated (Exact name of Registrant as Specified in Its Charter)

Delaware

000-50633

94-3291317

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

350 Oyster Point Boulevard

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 624-3000

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

CYTK

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 24, 2026, Cytokinetics, Incorporated announced its financial results for the fourth quarter and year ended December 31, 2025. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 2.02 and under Exhibit 99.1 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein. Item 9.01 Financial Statements and Exhibits. (d) Exhibits

99.1 Press Release dated February 24, 2026 104 The cover page of this report has been formatted in Inline XBRL

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CYTOKINETICS, INCORPORATED

Date:

February 24, 2026

By:

/s/ John O. Faurescu

SVP, Deputy General Counsel & Secretary